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Dermatology CRO - bioskin GmbH

bioskin is a full-service CRO specialized in dermatology which provides strategic and regulatory consulting, IND and NDA development for dermatology, ophthalmology and women’s health products, early phase safety and Proof-of-Concept studies, and global Phase II-IV trials for NCEs, new formulations with known actives and generics.

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bioskin is a full-service CRO specialized in dermatology which provides strategic and regulatory consulting, IND and NDA development for dermatology, ophthalmology and women’s health products, early phase safety and Proof-of-Concept studies, and global Phase II-IV trials for NCEs, new formulations with known actives and generics.
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Dermatology CRO - bioskin GmbH | bioskin-usa.com Reviews

https://bioskin-usa.com

bioskin is a full-service CRO specialized in dermatology which provides strategic and regulatory consulting, IND and NDA development for dermatology, ophthalmology and women’s health products, early phase safety and Proof-of-Concept studies, and global Phase II-IV trials for NCEs, new formulations with known actives and generics.

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1

Quality Management - bioskin GmbH

http://www.bioskin-usa.com/quality-management.html

Strategic Consulting and Regulatory. Multicenter, Multinational Trials. OTC and Claim Support. Program and Project Management. Bioskin at a glance. Strategic Consulting and Regulatory. Multicenter, Multinational Trials. OTC and Claim Support. Program and Project Management. Bioskin at a glance. As a modular service, bioskin offers independent audits for system/vendor audits or site audits within trials not conducted by bioskin. Strategic Consulting and Regulatory. Multicenter, Multinational Trials.

2

Data Management - bioskin GmbH

http://www.bioskin-usa.com/data-management.html

Strategic Consulting and Regulatory. Multicenter, Multinational Trials. OTC and Claim Support. Program and Project Management. Bioskin at a glance. Strategic Consulting and Regulatory. Multicenter, Multinational Trials. OTC and Claim Support. Program and Project Management. Bioskin at a glance. Data management services are offered as stand-alone services for dermatological and other therapeutic areas as well as part of full packages and include:. CRF development and instructions for investigator/monitor.

3

Safety - bioskin GmbH

http://www.bioskin-usa.com/safety.html

Strategic Consulting and Regulatory. Multicenter, Multinational Trials. OTC and Claim Support. Program and Project Management. Bioskin at a glance. Strategic Consulting and Regulatory. Multicenter, Multinational Trials. OTC and Claim Support. Program and Project Management. Bioskin at a glance. Investigation of cutaneous safety is a critical component of product development for both topical products and transdermal systems. Designs for evaluation of safety include:. Dermal irritation (diverse models).

4

Medical Writing - bioskin GmbH

http://www.bioskin-usa.com/medical-writing.html

Strategic Consulting and Regulatory. Multicenter, Multinational Trials. OTC and Claim Support. Program and Project Management. Bioskin at a glance. Strategic Consulting and Regulatory. Multicenter, Multinational Trials. OTC and Claim Support. Program and Project Management. Bioskin at a glance. Medical writing services are offered as stand-alone services for dermatological and other therapeutic areas as well as part of full packages and include:. Preparation of appendices for CSRs. Multicenter, Multinati...

5

Strategic Consulting and Regulatory - bioskin GmbH

http://www.bioskin-usa.com/strategic-consulting-and-regulatory.html

Strategic Consulting and Regulatory. Multicenter, Multinational Trials. OTC and Claim Support. Program and Project Management. Bioskin at a glance. Strategic Consulting and Regulatory. Multicenter, Multinational Trials. OTC and Claim Support. Program and Project Management. Bioskin at a glance. Strategic Consulting and Regulatory. Preparation/Review of Regulatory filings. IND, NDA, 505(b)(2), ANDA, MAA, Annual Reports, Combo product, Ophan Drug and Fast Track designations). OTC and Claim Support.

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Dermatology CRO - bioskin GmbH

Strategic Consulting and Regulatory. Multicenter, Multinational Trials. OTC and Claim Support. Program and Project Management. Bioskin at a glance. Strategic Consulting and Regulatory. Multicenter, Multinational Trials. OTC and Claim Support. Program and Project Management. Bioskin at a glance. Your partner for dermatology development. Strategic Consulting and Regulatory. Development strategy, regulatory guidance, INDs/CTAs, NDAs/MAAs. POC, safety, multicenter, multinational. OTC and Claim Support. 6th A...

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Dermatology CRO - bioskin GmbH

Strategic Consulting and Regulatory. Multicenter, Multinational Trials. OTC and Claim Support. Program and Project Management. Bioskin at a glance. Strategic Consulting and Regulatory. Multicenter, Multinational Trials. OTC and Claim Support. Program and Project Management. Bioskin at a glance. Your partner for dermatology development. Strategic Consulting and Regulatory. Development strategy, regulatory guidance, INDs/CTAs, NDAs/MAAs. POC, safety, multicenter, multinational. OTC and Claim Support. 6th A...

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